Device Classification Name |
tube, feeding
|
510(k) Number |
K071191 |
Device Name |
NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT |
Applicant |
NOVARTIS NUTRITION CORP. |
1541 PARK PLACE BLVD. |
ST. LOUIS PARK,
MN
55416
|
|
Correspondent |
TUV SUD AMERICA INC. |
1775 OLD HIGHWAY 8 NW |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
LAURA DANIELSON |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 04/30/2007 |
Decision Date | 07/23/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|